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510(k) K941426

SYMBIOSIS REUSABLE MONOPOLAR ELECTROSURGICAL PROBE by Symbiosis Corp. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1994
Date Received
March 24, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Symbiosis Corp.

  • K955119 — SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES (January 18, 1996)
  • K953453 — SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES (January 17, 1996)
  • K953242 — SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES (October 6, 1995)
  • K952432 — SYMBIOSIS BIPOLAR FORCEPS (July 5, 1995)
  • K951387 — SYMBIOSIS BIPOLAR SCISSORS (April 10, 1995)
  • K950286 — SYMBIOSIS BIPOLAR SCISSORS (February 3, 1995)
  • K946238 — SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS (January 20, 1995)
  • K930773 — SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS (July 28, 1994)
  • K932266 — SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN (March 15, 1994)
  • K931957 — SYMBIOSIS DISPOSABLE UROLOGICAL BIOPSY FORCEPS (February 28, 1994)

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